AABB is an international
association dedicated to advancing transfusion and cellular therapies worldwide.Our members include 1800 hospital and community blood
centers, transfusion and transplantation services and 8000 individuals involved
in activities related to transfusion and transplantation medicine. For over 50
years, AABB has established voluntary standards and inspected and accredited
institutions. Our members are responsible for virtually all of the blood
collected and more than 80 percent of the blood transfused in this country.
AABB’s highest priority is to maintain and enhance the safety and availability
of the nation's blood supply.

At this meeting of the Blood Products Advisory Committee
(BPAC), the committee has been asked to consider the extent to which available
scientific data may support potential changes to further standardize processing
of plasma products for transfusion and to identify additional scientific
studies that would be helpful to resolve current areas of uncertainty.In preparation for this meeting, AABB
consulted its Clinical Transfusion Medicine Committee (CTMC) to determine how
various plasma components are being used in clinical practice and if changes in
preparation of these components would improve clinical outcomes. Plasma is most
commonly transfused into patients with multiple coagulation defects. The most
common uses are for patients undergoing surgery and experiencing surgical blood
loss, trauma patients, patients with impaired clotting resulting from liver
disease, patients on excessive coumadin therapy, and treatment of patients with
Thrombotic thrombocytopenic purpura (TTP).

For treatment of the conditions listed above, Factor VIII
levels in the transfused plasma are not critical to the therapeutic effect of
the component. Specifically, Factor VIII levels in patients experiencing
general surgical bleeding are usually above normal, since Factor VIII is an
acute stress response protein. In patients with liver disease, Factor VIII
levels are generally normal. Factor VIII plays no role in coumadin
reversal.The CTMC noted that Factor
VIII is critical only in the case of treatment of Factor VIII deficiency.In that case, plasma components would be
used to treat Factor VIII deficiency only in the rare instance that factor
concentrate is not available.

Fresh Frozen Plasma (FFP), Plasma Frozen Within 24 Hours
of Collection (FP24), and Thawed Plasma are used interchangeably in many
facilities, especially at large tertiary care hospitals with busy Level I
trauma centers. One of the physician members of the CTMC also reported using
these components interchangeably in a busy therapeutic apheresis center. There
are, however, specific treatment indications for FFP and FP24; an example is
the treatment of neonates with coagulopathies. In summary, when used
appropriately, FFP, FP24 and Thawed Plasma are all widely used and can produce
good clinical outcomes.

AABB
believes there is no current problem with the efficacy of plasma for
transfusion. In the absence of new data, therefore, there is no clinically
compelling reason to require changes in the preparation and storage of plasma
components.In fact, much of the
literature reviewed at this meeting attempts to judge the quality of plasma for
transfusion through the measurement of Factor VIII levels in the components. As
noted above, Factor VIII is generally not clinically relevant to the
therapeutic benefit of plasma components. In addition, AABB cautions that
Factor VIII is not an appropriate surrogate for the measurement of levels of
other more stable coagulation factors in stored plasma components. There is no
evidence that adding a requirement aimed at preserving Factor VIII content
would result in an increase in the therapeutic value of plasma components.
Furthermore, such a requirement could send clinicians the erroneous message
that FFP can be used for Factor VIII replacement, when that component is
clearly not the treatment of choice in case of Factor VIII deficiency.

AABB
believes that, given all of the competing priorities in transfusion medicine,
there is no need to require changes in present methods of preparation of plasma
for transfusion.

Any changes to regulation should be based on evidence of
beneficial clinical outcomes.AABB
believes that the time and effort spent in reducing inappropriate ordering of
plasma transfusions by clinicians would produce greater benefits to patients
than would result from focusing on changes in plasma preparation. A commitment
of resources and research dollars to the plasma production area will detract
from other issues that can better benefit clinical outcomes.